NIPT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-29 for NIPT manufactured by Panoroma.

Event Text Entries

[30991390] This is in regards to the panorama nipt screening test. This is my story: the only screening we chose to do in my pregnancy was originally the nipt trisomy 13, 18 and 21. When we received the form for the nipt, i checked off the microdeletion test boxes thinking "why not? ", well now i know why i would never check off those boxes again. The test results came back fine for trisomy 13/18/21 but with "high risk" (1 in 19 chance) for digeorge microdeletion 22q11. I was very stressed about this result and we decided to have the amnio after having met with a genetics counselor. The first thing she said was that she tells all people she's counseling to not get the microdeletion tests which have a (b)(4) false positive rate. In my research (after i had the test), i also saw a post by an obgyn who said they do not allow these microdeletion tests to be done in their clinic - only trisomy. It is ridiculous that this test can even go to the market. The amnio went well and it took 10 days for the microdeletion tests to come in. I received the call and it turns out it was yet another false positive. This was a very traumatic experience. After all my research, i would never have the microdeletion nipt test again, nor do i feel it should be offered with such a low rate of accuracy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5057632
MDR Report Key5201140
Date Received2015-10-29
Date of Report2015-10-29
Date of Event2015-10-01
Date Added to Maude2015-11-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNIPT
Generic NameSCREENING TEST
Product CodePCA
Date Received2015-10-29
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPANOROMA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-10-29

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